FDA Adverse Event
Injury
Summary report: N
ARTICULEZE M 28MM 8.5
MDR report key: 1051152
·
Received May 21, 2008
Report
- Report Number
- 1818910-2008-01973
- Event Type
- Injury
- Date Received
- May 21, 2008
- Date of Event
- May 6, 2008
- Report Date
- May 26, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD
- Product Code
- LPH
- PMA / PMN Number
- K883460
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICULEZE M 28MM 8.5 | 87LPH | LPH | DEPUY INTERNATIONAL, LTD | NA | 2445772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |